Recall archive / FDA device enforcement
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. — FDA record Z-1518-2022
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
- Reason
- Incorrect optical calibration
- Classification
- Class II
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 1
- Agency-reported status
- Completed
- Source record identifier
- Z-1518-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial Number 00654 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
There was only foreign distribution to Italy.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 24, 2022
- Recall initiation date
- Jul 19, 2022
- Center classification date
- Aug 12, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.